ArthritisNCT05003414
The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study
An observational study of Arthritis and Traumatic Arthritis, run by Medacta International SA at 5 sites in 2 countries.
Trial summary
This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- GMK Sphere cementless Knee Replacement
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Jan 2020to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring Total Knee Arthroplasty and who are suitable to receive Medacta GMK Sphere cementless Knee Replacement will be proposed to take part to the current post-market surveillance study during their pre-operative visit.
Who may be able to join
- A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
- Patients between the age of 18 and 80 at the time of consent
- Listed for total knee replacement surgery.
- Patients who are willing and able to give informed written consent
Who cannot join
- Progressive local or systemic infection
- Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
- Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- Patient whose BMI exceeds 40
- Any case not described in the inclusion criteria
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Clinique Saint Vincent de Paul
Bourgoin, 38300
Clinique du Parc
Caen, 14000
Hôpitaux Civils de Colmar
Colmar, 68000
Clinique des Acacias
Cucq, 62780
About this study
Official title: A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis
This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.
- Being tested
- GMK Sphere cementless Knee Replacement
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMK Sphere cementless Knee ReplacementDevice
Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Kaplan Meier method
Measured: 10 years
Secondary outcomes (4)
Clinical outcome: Knee Society score
Knee Society Score (KSS): evaluates pain, in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability.
Measured: Preop and 1, 2, 5, 10 years postop
Patient-reported outcome: Forgotten Joint Score
Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment.It consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Measured: 1, 2, 5, 10 years postop
Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence
Presence of radiolucencies, migration, loosening, subsidence
Measured: Immediately postop + 1, 2, 5, 10 years postop
Intraoperative and postoperative Adverse events
Intraoperative and postoperative adverse events
Measured: Intraop + Immediately postop + 1, 2, 5, 10 years postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start14 Jan 2020
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Marchetti, MD, Principal investigator, Clinique Saint Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003414
- Sponsor's protocol ID
- P02.014.26
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis
- ClinicalTrials.gov ID
- NCT05003414
- Acronym / sponsor ID
- P02.014.26
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring Total Knee Arthroplasty and who are suitable to receive Medacta GMK Sphere cementless Knee Replacement will be proposed to take part to the current post-market surveillance study during their pre-operative visit.
Key inclusion criteria (4 listed)
- A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
- Patients between the age of 18 and 80 at the time of consent
- Listed for total knee replacement surgery.
- Patients who are willing and able to give informed written consent
Key exclusion criteria (6 listed)
- Progressive local or systemic infection
- Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
- Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- Patient whose BMI exceeds 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMK Sphere cementless Knee ReplacementPerformance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement | Device | – |
Primary outcome
Survival rate
Time frame: 10 years
Kaplan Meier method
4 secondary outcomes
Clinical outcome: Knee Society score
Time frame: Preop and 1, 2, 5, 10 years postop
Patient-reported outcome: Forgotten Joint Score
Time frame: 1, 2, 5, 10 years postop
Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence
Time frame: Immediately postop + 1, 2, 5, 10 years postop
Intraoperative and postoperative Adverse events
Time frame: Intraop + Immediately postop + 1, 2, 5, 10 years postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Marchetti, MD principal investigator
Clinique Saint Vincent de Paul
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Traumatic Arthritis, run by Medacta International SA at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.